This invention relates to an improved universal resealable transfer set for transferring fluid, including drugs, vaccines, medicaments, solutions and the like, between a first container, such as a conventional vial having a pierceable elastomeric closure or stopper, and a second container, such as a conventional syringe having a luer connector. The transfer set assembly includes a fluid transfer member having a resealable valve member which permits repeated use of the transfer set for transferring fluid between the first and second containers.
It is conventional to store drugs, vaccines, solutions and medicaments in a sealed vial or other container for later use. Such materials may be in a dry or powdered form to increase the shelf life and reduce inventory space. Such dry or powdered materials may be stored in a conventional sealed vial having an elastomeric stopper and reconstituted in liquid form for administration to a patient by adding a diluent or solvent. Alternatively, the material may be stored in liquid or even a gaseous form. A conventional vial for storing drugs, vaccines, medicaments and the like, generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper which generally includes a generally tubular portion inserted into the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).
Recently, various vial transfer sets have been proposed for transferring fluid between a vial and a conventional syringe wherein the transfer set is mounted on the vial for later use. The proposed transfer sets, however, do not permit multiple uses of the transfer set, limiting their use to one application. The transfer set may include a piercing member, such as a needle cannula, generally telescopically mounted in a tubular fluid transfer member mounted on the open end of the vial. The transfer set may be enclosed by cup-shaped closure having a radial flange portion secured to the vial by malleable metal or plastic collar. Examples of such improved transfer sets include U.S. Pat. No. 6,003,566 assigned to the assignee of this application and pending application Ser. No. 09/168,502, filed Oct. 8, 1998 assigned to the assignee of this application, the disclosures of which are hereby incorporated by reference in their entirety.
As set forth above, however, the prior proposed vial transfer sets are not resealable and are therefore limited to a single use. U.S. Pat. Nos. 5,474,544, 5,549,651 and 5,697,915 disclose luer receiving medical valves having a slit silicone membrane and which eliminates the requirement for a needle cannula on the syringe, sometimes referred to as a xe2x80x9cluer slip connector.xe2x80x9d The medical valve disclosed in these patents are not, however, readily adaptable to a transfer set because the longitudinally slit cylindrical polymeric membrane must first be moved within the valve to a larger diameter chamber and then compressed by the luer slip connector of the syringe to expand and open the slit for transfer of fluid. Further, the luer receiving medical valve disclosed in these patents do not provide for piercing of a closure, such as the pierceable stopper of a conventional vial.
The need therefore remains for a universal transfer set suitable for use with a conventional sealed vial for transfer of fluids between a vial and a second container, such as a conventional syringe, whereby the transfer set is resealable for multiple applications. The resealable transfer set of this invention fulfills this need in a simple, reliable design, which is easily used by a healthcare worker. The resealable transfer set of this invention can be utilized to transfer fluids between a conventional vial having a conventional elastomeric stopper and a conventional syringe without a needle cannula. However, the improved resealable transfer set of this invention is universal in that it can be used to transfer any fluid between a first container having a pierceable closure and a second container.
As set forth above, the resealable transfer set of this invention may be utilized for transferring fluid between a first container having a pierceable closure, such as a conventional vial having an elastomeric stopper, and a second container, such as a conventional syringe without requiring a needle cannula. The transfer set includes a unique generally tubular elastomeric fluid transfer valve member, preferably molded of sterilizeable silicone, including an open end portion coaxially aligned with the container opening and a generally closed distal end portion having a longitudinal slit therethrough. A piercing member is telescopically received in the fluid transfer valve member through the open end including a piercing end adjacent the pierceable closure of the first container and a distal end adjacent the generally closed end of the fluid transfer valve member opposite and most preferably adjacent the longitudinal slit. For ease of description, the portions of the transfer set adjacent the pierceable closure or elastomeric stopper are referred to as xe2x80x9cproximatexe2x80x9d and the portions remote from the pierceable closure are referred to as xe2x80x9cdistal.xe2x80x9d
Fluid may then be transferred between the first container and the second container by driving a tubular portion of the second container through the slit in the distal end of the elastomeric fluid transfer valve member against the piercing member, which drives the piercing end through the pierceable closure. Although the resealable transfer set of this invention may be utilized for transferring fluids between various containers, and is therefore not limited to the types of containers utilized, one important advantage of the resealable transfer set of this invention is that it may be utilized to transfer fluids between a conventional vial sealed with a conventional elastomeric stopper and a conventional syringe having a luer slip connector. Thus, the resealable fluid transfer set will now be described for use with a conventional vial and syringe for ease of description.
The preferred embodiment of the tubular connector member includes a male luer connector at its distal end which receives the luer connector of a conventional syringe having a female luer connector. Threading of the luer connector of the syringe on the luer connector of the tubular luer connector member drives the tubular end of the syringe through the longitudinal slit against the distal end of the piercing member, driving the piercing end through the elastomeric stopper and establishing fluid communication between the syringe and the vial. In the preferred embodiment, the piercing member includes a generally longitudinal channel, establishing fluid communication between the vial and the syringe through the generally tubular elastomeric fluid transfer valve member. In the most preferred embodiment, the free distal end of the elastomeric fluid transfer valve member includes a radial annular lip portion which is received over the distal end of the generally tubular luer connector member, supporting and retaining the tubular elastomeric fluid transfer member. Further, the generally tubular elastomeric fluid transfer valve member includes an outwardly tapered or conical enlarged tubular portion adjacent the generally closed distal end portion which is generally hourglass-shaped and the distal end of the piercing member includes an enlarged conical head portion, such that the piercing member is releasably retained in the elastomeric fluid transfer valve member during assembly and prior to use. The preferred embodiment of the generally tubular luer connector member then includes a lateral opening or openings which permits lateral expansion of the conical portion of the fluid transfer valve member and release of the piercing member.
Upon removal of the tubular portion of the syringe or second container from the longitudinal slit in the generally closed distal end portion of the fluid transfer valve member, the slit closes effectively resealing the transfer set for later use. All that is required for later reuse is to swab the surface of the exposed closed distal end with a suitable sterilizing fluid. Thus, the resealable transfer set of this invention is suitable for multiple uses, permitting storage of a greater quantity of medicament in the vial.
The preferred embodiment of the resealable transfer set of this invention further includes a cup-shaped closure surrounding the luer connector member including an open end having a radial flange portion mounted on the vial by a collar, such as a conventional malleable aluminum collar or an improved plastic collar as disclosed in the above-referenced U.S. Pat. No. 6,003,566, the disclosure of which is incorporated herein by reference. The cup-shaped closure surrounds the generally tubular luer connector member and the elastomeric fluid transfer valve member and includes a closed distal end. In a most preferred embodiment, the collar includes a first proximate tubular portion which is received around the radial flange portion of the closure, the planar rim portion of the elastomeric stopper and the rim of the vial including a free end deformed or otherwise received in the neck portion of the vial, and a second distal tubular portion which surrounds the proximate tubular portion of the closure or cap and the closure includes a frangible portion located within the second distal tubular portion of the collar. The closure is then removed by breaking the frangible connection, exposing the generally closed distal end portion of the fluid transfer valve member for receipt of the tubular portion of a syringe or other container.
As described more fully in the above-referenced co-pending patent application Ser. No. 09/168,502, the plastic collar or closure may be formed of a polymer alloy or melt blend which includes a relatively tough soft malleable co-polymer and a relatively rigid polymer, such that the free end of the proximate tubular portion may be deformed or crimped into the reduced diameter neck portion of the vial. The preferred relatively rigid polymer is a polyamid or a polycarbonate and the preferred relatively soft co-polymer may be selected from polyesters or polyolefins. The resultant polymer alloy or composite preferably has an elongation that yield between 5% and 10% and an elongation at break greater than 100% with a flectural modulus of greater than 1900 MPa. Suitable polymers for the plastic collar of the transfer set of this invention include EASTAROR(copyright) polymers, which are melt blend and alloy polymers and EASTAR(copyright) thermoplastic polymers, which are neat polymers sold by Eastman Chemical Company of Kingsport, Tenn. and Eastman Chemical AG of Zug, Switzerland under the tradenames xe2x80x9cDA003,xe2x80x9d xe2x80x9cDN003xe2x80x9d and xe2x80x9cDN004.xe2x80x9d Other polymers having similar properties will also be suitable for this application. Alternatively, the collar may be formed of a malleable metal, such as aluminum, as disclosed in the above-referenced U.S. Pat. No. 6,003,566.
The transfer set of this invention may be assembled prior to application to a vial by telescopically receiving the piercing member in the generally tubular elastomeric fluid transfer valve member, which is releasably retained in the fluid transfer valve member as described above. The fluid transfer valve member and piercing member may then be inserted into the generally tubular luer connector member, which is retained in place by the radial annular lip portion described above, and the assembly received in the cup-shaped closure and collar which, in the disclosed embodiment, is retained to the closure by lip received in a groove in the collar.
The transfer set assembly of this invention is resealable and suitable for multiple uses as described above and the design is relatively simple and may be manufactured at relatively low cost. The transfer set assembly is also reliable and simple to use for transferring fluids between a vial and a syringe by healthcare workers. Other advantages and meritorious features of the present invention will be more fully understood from the following description of the preferred embodiments, the appended claims and the drawings, a brief description of which follows.